New Delhi: In a major relief to the pharmaceutical sector, the Delhi high court on Thursday quashed a government-imposed ban on fixed dose combination (FDC) drugs.
The cases—filed by several drug companies in as many as 454 petitions—question the validity of the ban imposed by the government on FDC drugs. This was based on a 10 March notification, by which the government banned 344 FDC drugs, which extended to about 6,000 brands, citing health risks and lack of any therapeutic justification.
Justice Rajiv Sahai Endlaw allowed the petitions of the drug companies, in effect setting aside the March notification.
An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses. These drugs are popular in India due to advantages such as increased efficacy, better compliance, reduced cost and simpler logistics of distribution.
During the hearings, the government maintained that the ban was in public interest as the combination drugs were not safe for health and have been banned in several other countries.
Drug companies moved the high court against the government’s March ban order. In a relief to the pharma companies, the Delhi high court stayed the ban order when the cases were being heard. Pfizer Ltd was the first to get a stay on the ban of its Corex cough syrup.
The court reserved its verdict in the case on 2 June.
Some major companies involved in the case are Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd, Sun Pharmaceuticals.
The major brands included in the ban were P&G’s cold and cough drug Vicks Action 500 Extra, Pfizer India’s Corex, Piramal’s Saridon, Reckitt’s D Cold Total and Glenmark’s Ascoril-C.
Delhi HC strikes down ban on 344 fixed-dose combination drugs The Delhi High Court today quashed the government notification on March 10 that banned 344 fixed-dose combination drugs. Moneycontrol Bureau The Delhi High Court today quashed the government notification on March 10 that banned 344 fixed-dose combination drugs. About 454 petitions were filed by drug and healthcare majors challenging the Centre’s decision to ban 344 fixed dose combination (FDC) medicines, including well known brands like Corex cough syrup, Vicks Action 500 extra and D’Cold. Justice Rajiv Sahai Endlaw on June 2 had reserved the order after hearing regular arguments of companies like Pfizer, Glenmark, Procter and Gamble and Cipla , the central government and some NGOs like All India Drug Action Network (AIDAN) over a span of over two months, starting from March 14. The court had on March 14 stayed the Centre’s March 10 ban on 344 FDC drugs and this interim order was passed in each and every case filed before it thereafter. During arguments, the drug companies had contended that the government has not properly implemented the powers under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act, under which the ban was ordered.
